Tarsus Pharmaceuticals, Inc. (NASDAQ: TARS), a late clinical-stage
biopharmaceutical company whose mission is to focus on unmet needs
and apply proven science and new technology to revolutionize
treatment for patients, starting with eye care, today announced new
data from its Saturn-1 Phase 2b/3 pivotal trial and the Titan
real-world collarette prevalence study at the American Society of
Cataract and Refractive Surgery (ASCRS) 2021 Annual Meeting. The
new Saturn-1 data reinforce the strong potential clinical utility
of TP-03 (lotilaner ophthalmic solution, 0.25%) for the treatment
of Demodex blepharitis, with a broad range of patients showing a
substantial response. The Titan study revealed the high prevalence
of Demodex blepharitis in all-comer eye care patients in the U.S.
across diverse populations and geographies, including significant
overlap with some of the most commonly seen patients, such as those
taking prescription dry eye treatments.
“We are very encouraged by the additional Saturn-1 data points,
demonstrating that nearly all patients experienced a substantial
response, and the clinical value that TP-03 may have for both
patients and eye care professionals who have long struggled to
manage Demodex blepharitis – a disease with no existing approved
therapies,” said Bobak Azamian, M.D., Ph.D., President and Chief
Executive Officer of Tarsus. “We have received a lot of enthusiasm
and positive feedback on this new data from clinicians at the ASCRS
meeting. The compelling results of the Saturn-1 trial mark an
important step in our clinical program for TP-03 and bring us one
step closer to the development of a much-needed therapy for
patients suffering from this disease. Our second pivotal trial,
Saturn-2 is currently enrolling. If the topline results expected in
Q1 2022 are positive, we expect to submit a New Drug Application
next year for TP-03 for the treatment of Demodex blepharitis.”
Additional Saturn-1 Phase 2b/3 Results & Safety
Data
New Saturn-1 data presented at ASCRS today, demonstrated that,
in addition to achieving all primary and secondary endpoints, the
results showed a strong patient responder rate, as nearly all
Demodex blepharitis patients experienced a significant response to
treatment with TP-03. These findings indicate the substantial
potential impact this treatment may have for both patients and eye
care professionals. Results showed meaningful improvement in the
number of mites per lash as well as collarette grade reduction:
- 95% of TP-03 patients showed a significant response in mite
count, achieving ≤0.5 mites per lash at day 43 from an average
baseline of 3.2 mites per lash, compared to 36% of those on vehicle
(p<0.0001), with statistically significant results seen as early
as day 15.
- 93% of TP-03 patients improved by at least one collarette grade
by day 43, from an average baseline of grade 2.8 or approximately
100 collarettes per lid, compared to 50% of those on vehicle
(p<0.0001), with statistically significant results seen as early
as day 8.
In addition to the data presented at the ASCRS meeting, Tarsus
is also announcing results from additional Saturn-1 safety
analysis, which revealed that TP-03 had no clinically significant
effect on multiple safety measures including Corrected Distance
Visual Acuity (CDVA), corneal staining, and intraocular pressure
(IOP) and no significant findings from slit lamp biomicroscopy or
fundus exam. In addition, no impact to endothelial cell density
(ECD) was seen in a subset of 21 patients. ECD will be further
evaluated as part of the Saturn-2 trial plan. Analysis from
Saturn-1, along with previously announced data, reinforces that
TP-03 is potentially safe to use in a broad patient population.
Saturn-1 (Phase 2b/3) was a randomized, controlled, multicenter,
double-masked pivotal trial evaluating the safety and efficacy of
TP-03 in adults with Demodex blepharitis. Previously announced
Saturn-1 topline data showed that TP-03 met all its primary and
secondary endpoints, including improvements in lid margin redness,
with no serious treatment-related adverse events and no
treatment-related discontinuations.
The Saturn-1 trial was the first pivotal large-scale trial to
show positive, clinically meaningful and statistically significant
patient improvements for a therapeutic specifically designed to
treat Demodex blepharitis. TP-03 has the potential to be the first
U.S. Food and Drug Administration (FDA)-approved therapeutic for
Demodex blepharitis that targets the underlying cause of disease –
Demodex mite infestation.
Tarsus is currently proceeding with the second pivotal trial,
the Saturn-2 (Phase 3) trial, which has the same primary and
secondary endpoints as Saturn-1 and is expected to report topline
data results in Q1 2022.
Titan Study Results
The Titan study is an IRB-approved, retrospective chart review
of 1,032 patients across six U.S.-based ophthalmology and optometry
practices by seven investigators, designed to better understand the
prevalence of collarettes in U.S. eye care clinics. Collarettes, or
cylindrical dandruff, are a pathognomonic sign of Demodex
blepharitis and are an accumulation of mite waste product and eggs
that form at the base of the eyelashes. In data presented at ASCRS,
the Titan study revealed the presence of collarettes in 58% (n=595)
of patients. These results indicate a high prevalence of Demodex
blepharitis across diverse patient populations and geographies. The
study also revealed that the prevalence of Demodex blepharitis is
similar to that of dry eye (58%, n=593).
“The Titan findings are significant and help to quantify how
prevalent Demodex blepharitis is in real-life clinical practice,
with more than half of observed patients presenting with
collarettes,” said Ehsan Sadri, M.D., FACS, CEO and Founder of
Visionary Eye Institute, Newport Beach and Titan study presenter at
ASCRS. “The study also showed that collarettes are easy to identify
through a close evaluation of the upper eyelid when patients are
looking down during an eye exam. I look forward to the potential of
a new, effective treatment option that can provide relief for this
disease which impacts so many of my patients.”
The Titan study also found that most blepharitis patients (69%)
had collarettes, underscoring the role that Demodex mites play in
blepharitis cases. Additionally, 60% (n=135) of patients who were
on a dry eye prescription also had collarettes. Analysis of these
data suggest that these patients may have concomitant disease or
that Demodex blepharitis may be the root cause or an exacerbating
factor of their dry eye disease.
The Titan study findings are further supported by a prospective
independent study presented at ARVO 2021 (Teo et al), which found
that demodicosis was newly diagnosed in 55.3% of patients, with
61.8% and 68.3% noted to have blepharitis and dry eye,
respectively.
Archived videos of the ASCRS presentations can be accessed via
the following links:
- Safety and Efficacy of Topical Lotilaner, 0.25% for the
Treatment of Demodex Blepharitis: Results of the Phase 2b/3
Saturn-1 Trial
- The Prevalence of Collarettes and Demodex Blepharitis in
Ophthalmology and Optometry Practices
About TP-03TP-03 (lotilaner ophthalmic
solution, 0.25%) is a novel, investigational therapeutic designed
to resolve the signs of Demodex blepharitis by targeting and
eradicating the root cause of the disease – Demodex mite
infestation. TP-03 is a topical ophthalmic formulation of
lotilaner, which is a well-characterized anti-parasitic agent that
paralyzes and eradicates Demodex mites by selectively inhibiting
parasite-specific GABA-Cl channels. It is a potent, non-competitive
antagonist of insect and arachnid GABA-Cl channels and a highly
lipophilic molecule, which may promote its uptake in the oily sebum
of the hair follicle where the mites reside. TP-03 was evaluated in
the pivotal Saturn-1 (Phase 2b/3) trial involving 421 patients and
met all primary and secondary endpoints with no serious
treatment-related adverse events and no treatment-related
discontinuations. Prior to that, Tarsus also completed four Phase 2
clinical trials of TP-03 in Demodex blepharitis, all of which met
their respective endpoints with no significant adverse events nor
any events leading to treatment discontinuation. TP-03 is currently
being evaluated in the Saturn-2 (Phase 3) pivotal trial. If
approved, TP-03 may offer treatment for millions of patients around
the world with Demodex blepharitis.
About Demodex BlepharitisBlepharitis is a
common ocular condition that is characterized by inflammation of
the eyelid margin, redness and ocular irritation. Demodex
blepharitis is caused by infestation of Demodex mites, the most
common ectoparasite found on humans. Demodex blepharitis may affect
as many as 25 million Americans based on an extrapolation from the
Titan study indicating 58% of patients presenting to U.S. eye care
clinics have collarettes, a pathognomonic sign of Demodex
infestation, and another published study estimating that at least
45 million people annually visit an eye care clinic. Demodex
blepharitis can have a significant clinical burden and negatively
impact patients’ daily lives. Currently, there are no FDA-approved
treatments for Demodex blepharitis.
About Tarsus Pharmaceuticals, Inc.Tarsus
Pharmaceuticals, Inc. is a late clinical-stage biopharmaceutical
company that applies proven science and new technology to
revolutionize treatment for patients, starting with eye care. It is
advancing its pipeline to address several diseases with high unmet
need across a range of therapeutic categories, including eye care,
dermatology, and infectious disease prevention. The company is
studying two investigational medicines in clinical trials. Its lead
product candidate, TP-03, is a novel therapeutic being studied in a
second Phase 3 pivotal trial for the treatment of Demodex
blepharitis. TP-03 is also being developed for the treatment of
Meibomian Gland Disease. Tarsus is developing TP-05, an oral,
non-vaccine therapeutic for the prevention of Lyme disease, which
is currently being studied in a Phase 1 clinical trial.
Forward-Looking StatementsStatements in this
press release about future expectations, plans and prospects, as
well as any other statements regarding matters that are not
historical facts, may constitute “forward-looking statements.”
These statements includes statements regarding Tarsus’ plans for
and the anticipating benefits of its product candidates, including
TP-03, the timing, objectives and results of the clinical trials
and anticipated regulatory and development milestones, including
the timing of the Saturn-2 clinical trial and submission of an NDA,
and the quotations of Tarsus’ management. The words, without
limitation, “believe,” “contemplate,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “might,” “plan,”
“potential,” “predict,” “project,” “should,” “target,” “will,” or
“would,” or the negative of these terms or other similar
expressions are intended to identify forward-looking statements,
although not all forward-looking statements contain these or
similar identifying words. Actual results may differ materially
from those indicated by such forward-looking statements as a result
of various important factors. Important factors that could cause
actual results to differ materially from those in the
forward-looking statements include: Tarsus has incurred significant
losses and negative cash flows from operations since inception and
anticipates that it will continue to incur significant expenses and
losses for the foreseeable future; Tarsus may need to obtain
additional funding to complete the development and any
commercialization of its product candidates, if approved; Tarsus is
heavily dependent on the success of its lead product candidate,
TP-03 for the treatment of Demodex blepharitis; the COVID-19
pandemic may affect Tarsus’ ability to initiate and complete
preclinical studies and clinical trials, disrupt regulatory
activities, disrupt manufacturing and supply chain or have other
adverse effects on Tarsus’ business and operations; even if TP-03,
TP-05, or any other product candidate that Tarsus develops receives
marketing approval, Tarsus may not be successful in educating eye
care physicians and the market about the need for treatments
specifically for Demodex blepharitis, Lyme disease, and/or other
diseases or conditions targeted by Tarsus’ products; the
development and commercialization of Tarsus products is dependent
on intellectual property it licenses from Elanco Tiergesundheit AG;
Tarsus will need to develop and expand the company and Tarsus may
encounter difficulties in managing its growth, which could disrupt
its operations; the sizes of the market opportunity for Tarsus’
product candidates, particularly TP-03 for the treatment of Demodex
blepharitis and MGD, as well as TP-05 for the treatment of Lyme
disease, have not been established with precision and may be
smaller than estimated; the results of Tarsus’ earlier studies and
trials may not be predictive of future results; any termination or
suspension of, or delays in the commencement or completion of,
Tarsus’ planned clinical trials could result in increased costs,
delay or limit its ability to generate revenue and adversely affect
its commercial prospects; and if Tarsus is unable to obtain and
maintain sufficient intellectual property protection for its
product candidates, or if the scope of the intellectual property
protection is not sufficiently broad, Tarsus’ competitors could
develop and commercialize products similar or identical to Tarsus’
products. Further, there are other risks and uncertainties that
could cause actual results to differ from those set forth in the
forward-looking statement and they are detailed from time to time
in the reports Tarsus files with the Securities and Exchange
Commission, including Tarsus’ Form 10-K for the year ended December
31, 2020 filed with the SEC on March 31, 2021 and Form 10-Q for the
quarter ended March 31, 2021 filed with the SEC on May 11, 2021,
which Tarsus incorporates by reference into this press release and
copies of which are posted on its website and are available from
Tarsus without charge. However, new risk factors and uncertainties
may emerge from time to time, and it is not possible to predict all
risk factors and uncertainties. Accordingly, readers are cautioned
not to place undue reliance on these forward-looking statements.
Any forward-looking statements contained in this press release are
based on the current expectations of Tarsus’ management team and
speak only as of the date hereof, and Tarsus specifically disclaims
any obligation to update any forward-looking statement, whether as
a result of new information, future events or otherwise.
Contacts: Media Contact:SuJin Oh Shop PR(917)
841-5213sujin@shop-pr.com
Investor Contact:Patti BankWestwicke Partners, an ICR
company(415) 513-1284IR@tarsusrx.com
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